This invention relates to a process that produces ultra clean radiopharmaceutical reusable shipping canisters which are generally referred to as pigs; and more particularly for cleaning pigs utilized for shipping radioactive drugs having relatively short half lives, typically on the order of no more than a few days.
This invention is an improvement on the process disclosed and claimed in U.S. Pat. No. 7,825,392 to Rodney Wayne Prosser, the inventor in the present application, entitled Cleaning Process for Radiopharmaceutical Reusable Pigs; the disclosure and content of which patent (hereafter the “Prior Prosser Patent”) is hereby incorporated by reference.
Radioactive drugs are typically shipped by pharmacies to hospitals, clinics and medical offices, frequently for diagnostic purposes; but are at times utilized in “ultra clean” areas where a patient has internal tissues exposed, such as operating rooms, surgical suites or interventional procedure suites; or where the patient is otherwise at a greater than normal risk of contracting an infection. These ultra clean areas have filtered air and other features to minimize the presence of harmful microorganisms. The personnel working in these areas follow strict protocols to reduce the presence of pathogens that can cause harm to patients. These protocols include hand hygiene, gowning procedures, use of sterile gloves, and cleaning procedures for the room and equipment brought into the room. This is done to maintain a sterile or clean operating or procedure field and to greatly reduce the risk of infection.
The radioactive drugs are shipped in pigs, each of which has a lead surround for radiation shielding and an inner chamber that may contain a syringe or vial which is suitable for dispensing an individual dose of a radioactive drug.
The radiopharmaceutical pig typically is a two-part assembly, with an upper portion or cap threadably attached to the lower portion. The structure of a typical pig is shown in FIGS. 2 and 3 of the Prior Prosser Patent and described in the specification thereof, which also describes the manner in which the pig is utilized for transportation of the radioactive drug which is contained in a syringe or vial within the pig.
After the pig is delivered to the utilization site and the syringe or vial is removed and used, the syringe or vial is usually put back in the pig and the spent pig is returned to the pharmacy from which it came, for reprocessing.
Reprocessing of the spent pig is preferably done by the process described and claimed in the Prior Prosser Patent. This process results in a pig decontaminated to a level of cleanliness which is acceptable for most applications.
However, a significantly higher level of cleanliness is required for use in ultra clean areas.
A known approach to improving the cleanliness of the reprocessed pigs is to place the syringe or vial in a protective plastic insert within the internal cavity of the pig. See, for example, the article entitled The Incidence of Blood Contamination of Lead Unit Dose Containers With and Without Single-Use Protective Inserts Used with Commercially Prepared Radiopharmaceutical Unit Doses, by Martha W. Pickett, Judith E. Kosegi, Kathleen S. Thomas and Kristen M. Water-stram-Rich, Journal of Nuclear Medicine Technology, Volume 26, Number 3, September 1998, pages 200-203. However, this approach, while improving cleanliness, does not provide as high a level of cleanliness as is desirable for use in ultra clean areas.
Accordingly, an object of the present invention is to provide an improved process for cleaning radiopharmaceutical pigs that is better suited for use in ultra clean areas.